BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMR CEMENTLESS FINNED STEM

    MDR report key: 14049911 · Received April 8, 2022

    Report

    Report Number
    3008021110-2022-00024
    Event Type
    Injury
    Date Received
    April 8, 2022
    Date of Event
    March 28, 2022
    Report Date
    August 25, 2022
    Manufacturer
    LIMACORPORATE S.P.A.
    Product Code
    HSD
    PMA / PMN Number
    K101263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO ANOMALIES WERE FOUND ON THE ITEMS MANUFACTURED WITH THE INVOLVED LOT #S. THIS IS THE FIRST AND ONLY COMPLAINT RECEIVED ON THESE LOT #S/STER. WE WILL SUBMIT A FINAL MDR AS SOON AS THE INVESTIGATION WILL BE COMPLETED.

    Additional Manufacturer Narrative · 0

    CHECKING THE STERILIZATION CHARTS OF THE INVOLVED LOT #S, NO PRE-EXISTING ANOMALY WAS FOUND. THEREFORE, ALL THE PRODUCTS WITH THESE LOT #S HAVE BEEN PROPERLY STERILIZED BEFORE BEING PLACED ON THE MARKET. NO ADDITIONAL DETAILS WERE AVAILABLE ON THIS POST-OPERATIVE ISSUE, SPECIFICALLY THE FOLLOWING INFORMATION WAS REQUESTED TO THE COMPLAINT SOURCE, BUT IT WAS NOT AVAILABLE: X-RAYS PRE-OPERATIVE OR POST-OPERATIVE OF THE REVISION SURGERY; PATHOGEN RESPONSIBLE FOR THE INFECTION. BASED ON THE VERY FEW INFORMATION RECEIVED, WE ARE NOT ABLE TO FURTHER INVESTIGATE THE ROOT CAUSE OF THE EVENT. HOWEVER, CONSIDERING THAT THE CHECK OF THE STERILIZATION CHARTS HIGHLIGHTED NO ANOMALIES ON THE TOTAL NUMBER OF COMPONENTS MANUFACTURED WITH THE INVOLVED LOT #S, WE CAN STATE THAT THE EVENT WAS NOT PRODUCT RELATED. PMS DATA. ACCORDING TO LIMACORPORATE PMS DATA, REVISION RATE OF SMR REVERSE DUE TO INFECTION IS 0.069%. BASED ON THE ROOT CAUSE ANALYSIS PERFORMED AND ACCORDING TO THE RELEVANT PMS DATA, NO CORRECTIVE ACTIONS REQUIRED FOR THIS SPECIFIC CASE. LIMACORPORATE WILL CONTINUE MONITORING THE MARKET TO PROMPTLY DETECT ANY FURTHER SIMILAR ISSUE. NOTE: THIS IS A FINAL MDR.

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2022, DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.150, LOT #2119081, STER. 2100290); SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2125437, STER. 2200016); PRODUCT NOT SOLD IN THE US. SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2122898, STER. 2100350); PRODUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R - SCREW (PRODUCT CODE 1374.15.305, LOT #2201508, STER. 2200030) IT WAS REPORTED THAT SWABS WERE TAKEN FOR ANALYSIS. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, (B)(6) YEARS OLD. EVENT HAPPENED IN (B)(6).

    Description of Event or Problem · 0

    SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESIS PERFORMED ON (B)(6) 2022, DUE TO INFECTION. THE FOLLOWING COMPONENTS WERE REMOVED AND REPLACED: SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.150, LOT #2119081 - STER. 2100290) SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT #2125437 - STER. 2200016) - PRODUCT NOT SOLD IN THE US. SMR REVERSE HP LINER SHORT (PRODUCT CODE 1365.09.010, LOT #2122898 - STER. 2100350) - PRDUCT NOT SOLD IN THE US. SMR CONNECTOR SMALL R - SCREW (PRODUCT CODE 1374.15.305, LOT #2201508 - STER. 2200030). IT WAS REPORTED THAT SWABS WERE TAKEN FOR ANALYSIS, HOWEVER THE RESULTS ARE NOT KNOWN. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2022. PATIENT IS A FEMALE, 68 YEARS OLD. EVENT HAPPENED IN AUSTRALIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1881502 SMR CEMENTLESS FINNED STEM FINNED HUMERAL STEMS - 80MM (TI6AL4V) DIA.15MM HSD LIMACORPORATE S.P.A. 1304.15.150 2119081

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention